GSK's Exdensur Gets FDA Nod for Severe Asthma Treatment

Core Insights - GSK plc announced FDA approval for Exdensur (depemokimab-ulaa), an ultra-long-acting IL-5-targeting biologic, as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 and above [1] - Exdensur is the first and only ultra-long-acting biologic approved for severe eosinophilic asthma, administered twice yearly [1] FDA Approval and Clinical Data - The FDA approval was based on phase III SWIFT-1 and SWIFT-2 studies, which demonstrated a significant reduction in annualized asthma exacerbations with Exdensur compared to placebo [2] - Exdensur showed a 58% reduction in annualized exacerbations in SWIFT-1 and a 48% reduction in SWIFT-2 over 52 weeks compared to placebo [2] Safety and Tolerability - Treatment with Exdensur was generally well-tolerated, with side effects comparable to those of placebo [3] Stock Performance - GSK shares have increased by 26.3% over the past six months, outperforming the industry average rise of 22.1% [4] Development Activities - Exdensur is also under review for treating chronic rhinosinusitis with nasal polyps (CRSwNP) in the U.S., with a decision expected alongside the asthma indication [5][8] - In the UK, Exdensur was approved for both asthma with type 2 inflammation and CRSwNP [8] European Approval Status - The CHMP of the European Medicines Agency has issued a positive opinion for Exdensur for severe asthma with type 2 inflammation and CRSwNP, with a final decision expected in Q1 2026 [9] Respiratory Portfolio - GSK's respiratory portfolio is currently driven by Nucala, a monoclonal antibody targeting IL-5, which is approved for multiple IL-5-mediated conditions [10] - Nucala's sales increased by 13% at constant exchange rates to £1.44 billion in the first nine months of 2025, supported by strong market performance [12]